the Effectiveness of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures
NCT ID: NCT05588232
Last Updated: 2022-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2021-10-18
2022-02-24
Brief Summary
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The objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary angiography or angioplasty.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patient with virtual reality
The virtual reality sedation-analgesia solution developed by Deepsen combines 3D environment content with medical hypnosis techniques. The technology includes a wearable visual headset that contains head movement sensors, enabling patient interaction in the virtual environment, as well as isolating headphones.
scheduled outpatient interventions in interventional cardiology
coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)
Patient with pharmacological sedation
scheduled outpatient interventions in interventional cardiology
coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)
Interventions
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scheduled outpatient interventions in interventional cardiology
coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)
Eligibility Criteria
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Inclusion Criteria
* who must benefit from one of the following scheduled interventional cardiology outpatient procedures: coronary angiography, coronary angioplasty, peripheral angioplasty (lower limbs)
* Affiliation to a social security scheme or beneficiary of such a scheme.
* Patient having signed the free and informed consent
Exclusion Criteria
* Language barrier
* Claustrophobia
* Nausea
* History of intolerance to Virtual Reality
* Patient with epilepsy
* Refusal to participate in the study
* Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Unstable patient (state of shock, respiratory or neurological distress)
18 Years
ALL
No
Sponsors
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Elsan
OTHER
Responsible Party
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Locations
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Clinique Claude Bernard
Metz, , France
Countries
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Other Identifiers
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2021-A01130-41
Identifier Type: -
Identifier Source: org_study_id
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